CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 341 enrolled
Drug / intervention
LDV/SOF +1 moredrug
Likely dose
LDV/SOF 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01975675
NCT01975675Phase 3Completed
CompareCT.gov

A Phase 3b, Randomized, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin in Treatment-Naïve and Treatment-Experienced Japanese Subjects With Chronic Genotype 1 HCV Infection

Gilead Sciences·interventional·Posted Nov 5, 2013·Updated Nov 16, 2018

In Brief

A Phase 3 clinical trial evaluating LDV/SOF and RBV for Chronic HCV Infection. Completed, enrolled 341 participants across 19 sites.

Detailed Summary

This study will evaluate the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV) fixed-dose combination (FDC) tablet with or without ribavirin (RBV) in treatment-naive or treatment-experienced Japanese participants with chronic genotype 1 HCV infection. Participants receive 12 weeks of treatment and continue assessments during a 24-week posttreatment follow-up period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic HCV Infection
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 5, 2013
Enrollment StartOct 1, 2013
Primary CompletionJun 1, 2014
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 12.7 years ago

Interventions

LDV/SOFdrug

LDV/SOF 90/400 mg FDC tablet administered orally once daily

RBVdrug

RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, \> 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)